Cleared Traditional

MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI

K991299 · Princeton BioMeditech Corp. · Chemistry

May 1999

Decision

52d

Days

Class 2

Risk

About This 510(k) Submission

K991299 is an FDA 510(k) clearance for the MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI, a Chromatographic Separation, Cpk Isoenzymes (Class II — Special Controls, product code JHT), submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on May 28, 1999, 52 days after receiving the submission on April 6, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number	K991299 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 06, 1999
Decision Date	May 28, 1999
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement